Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00423410
Status:
COMPLETED
Last Update Posted:
2009-09-10
First Post:
2007-01-16
Brief Title:
A Safety Study of EPC2407 A Anti-Cancer Drug With Vascular Disrupting Activity In Patients With Advanced Cancer
Sponsor:
EpiCept Corporation
Organization:
EpiCept Corporation
Study Overview
Official Title:
A First In Man Phase I Study Of EPC2407 A Microtubule Inhibitor Anti-Cancer Drug With Tumor Vascular Endothelial Disrupting Activity Intravenous Administration Daily For Three Days In Patients With Advanced Solid Tumors And Lymphomas
Status:
COMPLETED
Status Verified Date:
2009-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate the safety pharmacokinetics PK and pharmacodynamic effects of a novel anti-cancer drug EPC2407 administered to patients with advanced cancer which have not responded to or have recurred following treatment with available therapies
Detailed Description:
This is a Phase I open label multicenter dose-escalation safety pharmacokinetic and pharmacodynamic study of EPC2407 administered intravenously over 60 minutes on a QDx3 schedule repeated every 21 days Patients are enrolled and dosed at the level defined by the escalation scheme The primary goal of the study design is to assess toxicity at the fixed dose levels according to the modified Fibonacci schema
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None